Kornimate/medical-research-clean huggingface dataset:
smart glucose meter project

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: currently, in the u.s., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. research has demonstrated that control of blood glucose (bg) reduces the complications of diabetes. as a result, almost half of americans diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their bg. the value of this approach is known to be limited by a high rate of patient non-compliance with bg testing, where patients test less often than prescribed. increased communication between patient and care manager along with feedback has been shown to increase self monitoring of blood glucose (smbg) test compliance. however, this feedback loop is largely absent from the current, episodic model of patient / care manager interaction and not available in existing bg meters given to diabetic patients. in this study, we propose to pilot test a cellular-embedded glucose meter. this device can transmit glucose readings directly over a cellular network to a care management server and then the patient will receive feedback on the screen of the glucose meter.

this research program will enroll participants in a 6-month pilot intervention study. in this study, 100 patients with diabetes (type 1 and type 2) who are known to be non-compliant with smbg will be enrolled and randomized to treatment groups (one group will receive a standard glucose meter and the second group will receive the cellular-embedded device) in order to achieve the following specific study aims; primary aim 1: determine if connecting diabetic patients to care managers via a cellular-enabled glucose meter with feedback will improve smbg testing compliance. secondary aim 2: determine if increased testing compliance leads to improvement in overall blood glucose control. this will be measured by a reduction of hba1c levels. secondary aim 3: determine whether this intervention leads to significant improvements in patient satisfaction with self-care and patient self-assessment of compliance.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * diagnosis of diabetes mellitus (type 1 or type 2) * currently, non-compliant with prescribed glucose testing regimen * hba1c of 7.5 or greater within the last six months exclusion criteria: * actively being treated for substance abuse * treatment for a thought disorder within the past year * non-english speaking * persons who are legally blind * women who are pregnant * cognitively or decisionally impaired as determined by practitioner * persons using an insulin pump

Keywords: smbg (self monitoring of blood glucose) diabetes mobile technology
shared decision making in parents of children with head trauma: head ct choice

Conditions: Head Injury

Summary: the investigators will test the impact of a decision aid, head ct choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.

the investigators' long term goal is to promote evidence-based, patient-centered evaluation in the acute setting, to more closely tailor testing to disease risk. the investigators will compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration through the following aim: test if the decision aid, head ct choice, improves validated patient-centered outcome measures and safely decreases healthcare utilization. the investigators will randomize at the clinician level. through the use of the intervention, head ct choice, the investigators aim to significantly increase parents' knowledge, engagement, and satisfaction, decrease the rate of head ct use, and decrease 7-day total healthcare utilization, with no significant increase in adverse events.

Eligibility criteria:
inclusion criteria: parents and their child, seeking care for a child who: 1. is \< 18 years of age; 2. had blunt trauma above the eyebrows (not isolated to face or eyes); 3. is positive for at least 1 of the pecarn clinical prediction rule predictors described below: pecarn predictors for children \< 2 years of age: severe mechanism (pecarn definition)\* loss of consciousness \> 5 seconds acting abnormally per parent initial ed gcs \< 15 by attending (or ct decision-maker) other signs of altered mental status (pecarn definition) presence of occipital, temporal or parietal scalp hematoma palpable skull fracture or unclear if skull fracture pecarn predictors for children 2-18 years of age: severe mechanism (pecarn definition)\* any loss of consciousness any vomiting since the injury severe headache in ed initial ed gcs \< 15 by attending (or ct decision-maker) other signs of altered mental status (pecarn definition)\*\* any sign of basilar skull fracture clinicians include attending physicians and fellows or midlevel providers caring for children with head trauma exclusion criteria: parents of children with: 1. gcs scores \< 15 2. evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination 3. brain tumors 4. ventricular shunts 5. bleeding disorder 6. pre-existing neurological disorders complicating assessment 7. neuroimaging at an outside hospital before transfer 8. signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication) 9. syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma 10. known to be pregnant 11. communication barriers such as visual or hearing impairment that may preclude use of the decision aid. 12. strong suspicion of abuse for this head injury

Keywords: head ct head injury pediatric emergency department decision aids shared decision making
impact of increased water intake in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the investigators have designed a randomized controlled trial to test whether increased water intake slows renal decline in patients with stage-iii chronic kidney disease. participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 l of water per day (depending on sex and weight), in addition to usual fluid intake, for one year. the investigators will calculate the change in kidney function (estimated glomerular filtration rate, measured every three months for 12 months), and compare renal decline between the intervention and control groups. the investigators hypothesize that increased water intake will slow renal decline.


Eligibility criteria:
inclusion criteria: * age 18-80 years * able to provide informed consent and willing to complete follow-up visits. * estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2 * trace protein or greater (albustix) or urine albumin/creatinine ratio \>2.8 mg/mmol (if female) or \>2.0 mg/mmol (if male) from a random spot urine sample exclusion criteria: * self-reported fluid intake \>10 cups/day or 24-hr urine volume \>3l. * enrolled in another trial that could influence the intervention, outcomes or data collection of this trial (or previously enrolled in this trial) * received one or more dialysis treatments in the past month * kidney transplant within past six months (or on waiting list) * pregnant or breastfeeding * history of kidney stones in past 5 years * less than two years life expectancy * serum sodium \<130 meq/l without suitable explanation * serum calcium \>2.6 mmol/l without suitable explanation * currently taking hydrochlorothiazide \>25 mg/d, indapamide \>1.25 mg/d, furosemide \>40 mg, or metolazone \>2.5 mg/d * currently taking lithium * patient is under fluid restriction (\<1.5 l a day) for kidney disease, heart failure, or liver disease, and meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction \<40%, nyha class 3 or 4, or end stage cirrhosis) or ii) hospitalization secondary to heart failure, ascites and/or anasarca * patient has gi disease (history of inflammatory bowel disease, crohns, etc.)

Keywords: chronic kidney disease estimated glomerular filtration rate water intake fluid intake renal decline
using cics-1 and spm-011 and ［18f］fbpa commissioned by cics and sumitomo heavy industries and stella pharma

Conditions: Thoracic Solid Malignant Tumor

Summary: to evaluate the safety and efficacy of boron neutron capture therapy (bnct) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. with "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for bnct using therapeutic ct to evaluate the safety and efficacy of bnct in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy. to evaluate the safety of ［18f］fbpa synthesized with mps200fbpa. in addition, the usefulness of ［18f］fbpa-pet testing to determine the appropriateness of performing bnct will be evaluated in an exploratory manner.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained from the subject. * patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma) * measurable disease, as defined by recist v1.1. * patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment. * patients with ecog performance status score of 0 or 1. * patients whose longest diameter sum of the lesions to be treated is 15 cm or less. exclusion criteria: * patients with active disease or active double cancers other than target lesions. * patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities * patients who received radiation therapy exceeding 65 gy as a prior treatment for the target lesion. * any serious concomitant disease that precludes completion of the study treatment. * patients with remaining complications of grade 3 or higher related to prior radiation therapy in the irradiation field.

Keywords: esophageal cancer non small cell lung cancer breast cancer malignant soft tissue sarcoma malignant pleural mesothelioma malignant peripheral nerve sheath tumors
safety and efficacy of brm421 for dry eye syndrome treatment

Conditions: Dry Eye Syndrome

Summary: the objective of this study is to compare the safety and efficacy of brm421 ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye.

this is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a reported history of dry eye for at least 6 months prior to enrollment; * have a history of use of eye drops exclusion criteria: * have any clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have used any eye drops within 2 hours of visit 1; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception
momordica charantia and dihydroartemisinin-piperaquined-primaquine for uncomplicated plasmodium falciparum malaria patients in southwest sumba regency

Conditions: Uncomplicated Plasmodium Falciparum

Summary: currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite effective in controlling malaria, however, the threat of spread of drug-resistant parasites has been reported. a study is conducted to assess the efficacy and safety extract of bitter melon (momordica charantia/mc) regimens compared to the combination of dihydroartemisinin piperaquine primaquine (dhp+pq) on the sexual and asexual stage of p. falciparum uncomplicated in sumba barat daya district, indonesia

the study was conducted in kori primary health cender, sumba barat daya district, east nusa tenggara province on sumba island. the study subject received either 3 day of dihydroartemisinin-piperaquine and primaquine 1 day on first day (dhp+pq) or extract of bitter melon (momordica charantia/mc) + placebo 1 day on first day according to their body weight. patients with fever or history of fever within the past 24 hours were screened by microscopic examination of giemsa stained tihick blood films to detect plasmodium falciparum infection. all patient were allocated by single blind randomization to receive dhp (on day 0 to day 2)+pq (on day 0 only) or extract of bitter melon (momordica charantia/mc) (on day 0 to day 2)+placebo (on day 0 only). the procedures of drug administration in the study were as follows:

Eligibility criteria:
inclusion criteria:- 1. age ≥ 18 years old male or female up to 60 years old 2. single plasmodium falciparum infection based on microscopic examination. 3. count the parasites for plasmodium falciparum at least 2 large visual field asexual parasites (lpb) by examining 15 lpb 4. density of parasites 1000-100,000/micro liter 5. has no history of uncontrolled comorbidities 6. history of fever in the last 24 hours for falciparum malaria 7. not taking other antimalarial drugs in the last 2 weeks. 8. have no previous history of malaria. 9. willing to come to the health facility according to the specified follow-up schedule. 10. willing to participate in research and established procedures. 11. there is no history of allergy to antimalarial drugs. exclusion criteria: 1. signs of general weakness, or decreased consciousness or recurrent seizures or circulation failure or pulmonary edema or signs of anemia or yellow body and slightly red urine. 2. if the examination results show mixed plasmodium and non-plasmodium falciparum. 3. has a history of severe liver, kidney and heart dysfunction, bradycardia and heart rhythm disturbances. 4. does not control regularly according to the research schedule 5. pregnant and lactating women 6. there are signs of severe malaria 7. patients with chronic diseases, for example: heart, kidney, liver, hiv. 8. mixed infection.

Keywords: parasite number, clinical symtomps, immunomodulator
precision cell immunotherapy combined with tace in advanced liver cancer

Conditions: Precision Cells; Chemotherapy; Advanced Lung Cancer

Summary: objectives: to evaluate the safety and effectiveness of cell therapy using precision cells to treat advanced lung cancer. eligibility: individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with advanced lung cancer.

a total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: * age 18\~65 years old, male or female; * life expectancy≥6 months; * ecog score: 0-3; * advanced malignancies (lung cancer) were diagnosed by pathological or clinical physicians; * enough venous channel, no other contraindications to the separation and collection of white blood cells; * laboratory examination: white blood cell≥3 x 10\*9/l, blood platelet count≥60 x 10\*/l,hemoglobin≥85g/l; lymphocyte count≥15%, total bilirubin≤100 mol/l; alt and ast less than five times of the normal level; serum creatinine less than 1.5 times of the normal level; * signed informed consent; * women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. exclusion criteria: * expected overall survival \< 6 months; * patients with uncontrolled hypertension (\>160/95mmhg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> class ii, nyha), or myocardial infarction within 6 months; * other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; * other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month; * unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Keywords: precision cells chemotherapy advanced lung cancer
stem cell transplant from donors after alpha beta cell depletion in children and adults with t-allo10 cells addback

Conditions: Hematologic Diseases

Summary: the purpose of this study is to determine the safety of a cell therapy, t-allo10, after αβdepleted-hsct in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe graft-versus-host disease (gvhd). the primary objective of phase 1a is to determine the recommended phase 2 dose (rp2d) administered after infusion of αβdepleted-hsct in children and young adults with hematologic malignancies. a phase 1b extension will occur after dose escalation, enrolling at the rp2d for the t-allo10 cells determined in the phase 1 portion to evaluate the safety and efficacy of infusion of t-allo10 after receipt of αβdepleted-hsct. additionally, phase 1b aims to explore improvements in immune reconstitution. all participants on this study must be enrolled on another study: nct04249830


Eligibility criteria:
inclusion criteria prior to enrollment: * 1. age \> 1 months (with minimum weight of 10 kg) and \< 45 years. * 2. patients deemed eligible for allogeneic hsct under the originating study, nct 04249830 * 3. patients with life-threatening hematological malignancies for which hsct has been recommended: 1. high-risk all in 1st cr, all in 2nd or subsequent cr; 2. high-risk aml in 1st cr, aml in 2nd or subsequent cr; 3. myelodysplastic syndrome; 4. jmml (juvenile myelomonocytic leukemia); 5. non-hodgkin lymphomas in 2nd or subsequent cr; 6. other hematologic malignancies eligible for stem cell transplantation per institutional standard. * 4. all subjects ≥ 18 years of age must be able to give informed consent, or adults lacking capacity to consent must have a lar available to provide consent. for subjects \ 7 years of age, when appropriate. inclusion criteria prior to t-allo10 infusion: 1. patient already received αβdepleted-hsct and has myeloid engraftment. 2. absence of active grade ii agvhd requiring \>0.5 mg/kg of steroids or any diagnosis of grade iii/ivagvhd. exclusion criteria prior to mnc collection for tallo-10 manufacturing.: 1. not eligible to receive hsct on nct04249830 2. received another investigational agent within 30 days of enrollment. 3. pregnancy (positive serum or urine beta-hcg) within 7 days of mnc donation. 4. patient or donor is not willing or able to undergo an additional non-mobilized apheresis for collection of mnc prior to donation of cells for participation in nct04249830.
study of a large protein molecule administered with escalating doses of recombinant human hyaluronidase

Conditions: Rheumatoid Arthritis

Summary: this phase iv, dose escalation, within-patient controlled study of pharmacokinetics (pk), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rhuph20) to a single dose administration of the large molecule with escalating doses of rhuph20. the study hypothesizes that an optimal dose of rhuph20 will increase the bioavailability of large molecule drug administration.

sequential enrollment into four rhuph20 dose cohorts.

Eligibility criteria:
inclusion criteria: 1. males or females at least 18 years of age with ra treated with mtx who have been treated with: * co-injected large molecule protein for at least two cycles, and * have had stable disease with no symptom flares in the previous 30 days. 2. ast (sgot) and alt (sgpt) within normal range within 7 days prior to entry in the study. 3. adequate venous access in at least one extremity. 4. a negative pregnancy test (if female of child-bearing potential) within 7 days prior to entry in the study. 5. decision-making capacity. 6. signed, written irb-approved informed consent. exclusion criteria: 1. unacceptable toxicity to the large molecule protein, or contraindication to or other reason to not continue the large molecule protein per the package insert (e.g., active or latent tuberculosis, chronic or localized infections, or concurrent treatment with anakinra). 2. history of active tuberculosis, or known positive tuberculin skin test unless the patient has successfully completed a nine-month course of isoniazid therapy. 3. concurrent use of any disease-modifying anti-rheumatic drug except the large molecule protein and mtx. 4. any anticipation that the dose of the large molecule protein or mtx would be changed within 4 weeks following entry in the study. 5. known allergy to hyaluronidase or any hyaluronidase product. 6. known allergy to bee or vespid venom. 7. contraindication to iv heparin lock or known hypersensitivity to heparin. 8. edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh. 9. presence of any other medical condition that would present an unacceptable safety risk to the patient. 10. participation in a study of any investigational drug or device within 30 days of enrollment in this study.